Spectral CT 7500 RT

K240844 · Philips Medical Systems Technologies , Ltd. · JAK · Oct 18, 2024 · Radiology

Device Facts

• Record ID: K240844
• Device Name: Spectral CT 7500 RT
• Applicant: Philips Medical Systems Technologies , Ltd.
• Product Code: JAK · Radiology
• Decision Date: Oct 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spectral CT 7000 family is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment parts, and accessories. The Spectral CT 7000 family system acquires one CT dataset - composed of data from a higher energy detected x-ray spectrum and a lower- energy detected x-ray spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment and radiation therapy planning/simulation usage only. This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society.

Device Story

Spectral CT 7500 RT is a whole-body CT system; utilizes rotating gantry with X-ray tube and dual-layer scintillator detectors (GOS + Photodiode). Acquires high/low energy datasets to analyze attenuation coefficient differences; enables material decomposition (e.g., iodine, calcium, uric acid) and effective atomic number mapping. Used in radiology, interventional radiology, cardiology, and radiation therapy planning. Operated by trained healthcare professionals. New features include Pulmonary Gating 4DCT for respiratory motion compensation and Extended Field of View (EFOV) up to 800mm for RT simulation. Output includes cross-sectional images, material density, and attenuation data. Benefits include improved anatomical visualization, material characterization, and motion-compensated planning for radiation therapy.

Clinical Evidence

No clinical study performed. Evidence consists of non-clinical bench testing, including motion phantom testing for Pulmonary Gating, spectral phantom testing, and external clinical image quality reviews by US board-certified reviewers for RT simulation suitability. All images rated satisfactory for intended use.

Technological Characteristics

Scanner system with rotating gantry, movable couch, operator console. Dual-layer spectral detector (solid-state yttrium-based scintillator, GOS + Photodiode). 120kW generator; 80-140 kVp range. 128-slice capability. Connectivity via DICOM 3.0. Software-based reconstruction. Complies with IEC 60601-1, 60601-1-2, 60601-2-44, and ISO 14971.

Indications for Use

Indicated for head, whole body, cardiac, and vascular CT applications in patients of all ages. Also indicated for low-dose CT lung cancer screening for early detection of lung nodules per established protocols.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Spectral CT (K203020)
• Philips CT Big Bore (K171850)

Submission Summary (Full Text)

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October 18, 2024

Philips Medical Systems Technologies Ltd. % Siwar Assi Regulatory Affairs Specialist Advanced Technology Center, Building 34, MATAM Haifa. 3100200 ISRAEL

Re: K240844

Trade/Device Name: Spectral CT 7500 RT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: March 27, 2024 Received: September 16, 2024

Dear Siwar Assi:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K240844

Device Name Spectral CT 7500 RT

### Indications for Use (Describe)

The Spectral CT 7000 family is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment parts, and accessories.

The Spectral CT 7000 family system acquires one CT dataset - composed of data from a higher energy detected x-ray spectrum and a lower- energy detected x-ray spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.

This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment and radiation therapy planning/simulation usage only.

This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society.

*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl. J Med 2011; 365:395-409) and subsequent literature, for further information.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. The word is likely a brand name or logo.

510(K) SUMMARY

## 510(k) Summary

K240844

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

| Date Prepared: | October 18, 2024 | | | |
|--------------------------------|-----------------------------------------------------------|----------------------------------------|--|--|
| Manufacturer: | Philips Medical Systems Nederland B.V.<br>Veenpluis 6, | | | |
| | 5684 PC BEST<br>The Netherlands | | | |
| | Establishment Registration Number: 3015777306 | | | |
| Primary Contact<br>Person: | Siwar Assi | | | |
| | Regulatory Affairs Specialist | | | |
| | Phone: [phone] | | | |
| | E-Mail: [e-mail] | | | |
| Secondary Contact<br>Person: | Carmit Shmuel<br>Regulatory Affairs Manager and Site Lead | | | |
| | Phone: [phone] | | | |
| | E-Mail: [e-mail] | | | |
| Device | Trade Name: | Spectral CT 7500 RT | | |
| | Common name: | Computed Tomography X-ray System | | |
| | Classification Name: | Computed Tomography X-ray System | | |
| | Classification Regulation: | 21CFR 892.1750 | | |
| | Classification Panel: | Radiology | | |
| | Device Class: | II | | |
| | Product Code: | JAK | | |
| Primary Predicate<br>Device: | Trade Name: | Spectral CT | | |
| | Manufacturer: | Philips Medical Systems Nederland B.V. | | |
| | 510(k) Clearance: | K203020 | | |
| | Classification Name: | Computed Tomography X-ray System | | |
| | Classification Regulation: | 21 CFR 892.1750 | | |
| | Classification Panel: | Radiology | | |
| | Device Class: | Class II | | |
| | Product Code: | JAK | | |
| Secondary Predicate<br>Device: | Trade Name: | Philips CT Big Bore | | |
| | Manufacturer: | Philips Medical Systems Nederland B.V. | | |
| | 510(k) Clearance: | K171850 | | |
| | Classification Name: | Computed Tomography X-ray System | | |
| | Classification Regulation: | 21 CFR 892.1750 | | |
| | Classification Panel: | Radiology | | |
| | Device Class: | Class II | | |
| | Product Code: | JAK | | |

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Spectral CT 7500 RT system is a whole-body computed tomography (CT) X-ray system featuring a Device

Description: c

Description: continuously rotating X-ray tube and detectors gantry, and multi slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This system also includes signals and display equipment, patient and equipment support, components, and accessories.

> The Spectral CT 7500 RT system acquires one CT dataset – composed of data from a higher energy detected X-ray spectrum and a lower- energy detected X-ray spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and provides information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. The Spectral CT 7500 RT system consists of three main components – a scanner system that includes a rotating gantry, a movable patient couch, and an operator control and image reconstruction; a Spectral Reconstruction System; and a Spectral CT Viewer. On the gantry, the main active components are the X-ray high voltage (HV) power supply, the X-ray tube, and the detection system.

The fundamental design and characteristics of the main components used in the proposed Spectral CT 7500 RT system are identical to the currently marketed primary predicate device, Spectral CT system (K203020). The Spectral CT 7500 RT system is a Computed Tomography X-ray system intended to produce cross-sectional Indications for Use: images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

> The Spectral CT system acquires one CT dataset – composed of data from a higher-energy detected X-ray spectrum and a lower- energy detected X-ray spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of atterial density, and effective atomic number.

This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment preparation and radiation therapy planning/simulation usage only.

This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.

*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl. J Med 2011; 365:395-409) and subsequent literature, for further information.

Based on the information provided above, the proposed Spectral CT 7500 RT system is considered substantially equivalent to the currently marketed primary predicate device, Spectral CT system (K203020), in terms of Indications for Use.

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### Technological Characteristics

The proposed Spectral CT 7500 RT system consonents – a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for control and image reconstruction System; and a Spectral CT Viewer. On the ganty, the main active components are the X-ray high voltage (HV) power supply, the X-ray tube, and the detection system. The design/fundamental scientific technology of both the proposed Spectral CT 7500 RT system and the currently marketed evice, Spectral CT system (K203020) are the same. The design changes (e.g. new software version and additional software features) do not change the

fundamental scientific technology of the proposed Spectral CT 7500 RT system.

The following table 1 lists the technological characteristics differences for the proposed Spectral CT 7500 RT system:

Table 1 Modifications made to the proposed device, Spectral CT 7500 RT system as compared to the currently marketed primary predicate device, Spectral CT system (K203020)

| Design Feature | Description |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pulmonary Gating 4DCT | Pulmonary gated scanning is a new feature that allows CT scan data to be collected along with the patient's breathing signal in order to allow the CT data to be reconstructed into specific phases of breathing. This allows patient anatomy to be visualized during a breathing cycle to allow for breathing motion of both the target as well as organs at risk to be compensated for during radiation therapy treatment planning. |
| Extended Field of View (EFOV) | EFOV is a feature that allows for a maximum reconstructed FOV of up to 800mm for non-gated Helical scans for RT simulation purposes only. |

| Table 2 Technological Characteristics Comparison | | | |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Feature | Currently Marketed Primary Predicate<br>Device: Spectral CT system (K203020) | Proposed Device:<br>Spectral CT 7500 RT system | Conclusion |
| Technological Characteristics | | | |
| Application | Head, Body and Cardiac | Head, Body and Cardiac | Identical, therefore, substantially<br>equivalent |
| Scan regime | Continuous Rotation | Continuous Rotation | Identical, therefore, substantially<br>equivalent |
| Scan Field of View | Up to 500 mm | Up to 800 mm | Substantially Equivalent.<br>Both the proposed device and the<br>predicate device include a Scannable Field<br>of View (SFOV) of 500mm used for<br>reconstructed images.<br>The improvement of the FOV in the<br>proposed device for up to 800mm<br>(Extended Field of View (EFOV)) is planned<br>for Radiation Therapy Planning |
| | | | procedures and is similar from a |
| | | | technology perspective to the secondary<br>currently marketed secondary predicate<br>device, Philips Big Bore system (K171850).<br>The SFOV was successfully verified and<br>validated and does not raise new<br>questions on safety and/or effectiveness. |
| No. of slices | Up to 128 slices of 0.625 mm | Up to 128 slices of 0.625 mm | Identical, therefore, substantially<br>equivalent |
| Scan modes | Surview<br>Axial-after-Axial<br>Dynamic Scan<br>Helical Scan | Surview<br>Axial-after-Axial<br>Dynamic Scan<br>Helical Scan | Identical, therefore, substantially<br>equivalent |
| Spatial Resolution - | 16 lp/cm max (high mode)<br>13 lp/cm max (standard mode) | 16 lp/cm max (high mode)<br>13 lp/cm max (standard mode) | Identical, therefore, substantially<br>equivalent |
| Minimum Scan time | 0.18 sec for 240° rotation,<br>0.27 sec for 360° rotation | 0.18 sec for 240° rotation,<br>0.27 sec for 360° rotation | Identical, therefore, substantially<br>equivalent |
| Scan coverage | Scanner Center of Rotation (COR) is up to<br>80 mm | Scanner Center of Rotation (COR) is up to 80 mm | Identical, therefore, substantially<br>equivalent |
| Low contrast resolution<br>(32cm body CTDI<br>phantom) | 4 mm @ 0.3% @ 25 mGy CTDIvol | 4 mm @ 0.3% @ 25 mGy CTDIvol | Identical, therefore, substantially<br>equivalent |
| Noise in (as standard<br>mode measured on 21.6<br>cm water-equivalent) | 0.27% at 27 mGy | 0.27% at 27 mGy | Identical, therefore, substantially<br>equivalent |
| Image Matrix | Up to 1024 x 1024 | Up to 1024 x 1024 | Identical, therefore, substantially<br>equivalent |
| Display | 1024 x 1280 | 1024 x 1280 | Identical, therefore, substantially<br>equivalent |
| Communication | Compliance with DICOM 3.0 | Compliance with DICOM 3.0 | Identical, therefore, substantially<br>equivalent |
| Detectors | | | |
| Type | Nano Panel Prism | Nano Panel Prism | Identical, therefore, substantially<br>equivalent |
| Material | Solid-state yttrium-based scintillator, GOS + Photodiode | Solid-state yttrium-based scintillator, GOS + Photodiode | Identical, therefore, substantially equivalent |
| DMS Detector Spectral CT 7500 | 8 cm - Dual-Layer scintillator, up to 128 detector rows | 8 cm - Dual-Layer scintillator, up to 128 detector rows | Identical, therefore, substantially equivalent |
| DMS structure | Spherical DMS structure | Spherical DMS structure | Identical, therefore, substantially equivalent |
| Collimation | 0.625 mm and various combinations, such as:<br>2x0.625, 16x0.625, 32x0.625, 64x0.625, 96x0.625, 112x0.625, 128x0.625 mm | 0.625 mm and various combinations, such as:<br>2x0.625, 16x0.625, 32x0.625, 64x0.625, 96x0.625, 112x0.625, 128x0.625 mm | Identical, therefore, substantially equivalent |
| Slice thicknesses | Various slice thickness options are available in the range of 0.67 - 10 mm for helical mode and 0.625 - 20 for axial mode | Various slice thickness options are available in the range of 0.67 - 10 mm for helical mode and 0.625 - 20 for axial mode | Identical, therefore, substantially equivalent |
| Gantry | | | |
| Gantry rotation speed | 0.27 sec -1.5 sec (360° rotation)<br>0.18 sec, 0.2 sec (240° rotation) | 0.27 sec -1.5 sec (360° rotation)<br>0.18 sec, 0.2 sec (240° rotation) | Identical, therefore, substantially equivalent |
| Bore size | 800 mm | 800 mm | Identical, therefore, substantially equivalent |
| Operator Controls located on Gantry | Touch Panel Controls | Touch Panel Controls | Identical, therefore, substantially equivalent |
| Eclipse Collimation | A-Plane | A-Plane | Identical, therefore, substantially equivalent |
| Generator and Tube Performance | | | |
| Power | 120kW | 120kW | Identical, therefore, substantially equivalent |
| kV Setting | 80 100 120 140 | 80 100 120 140 | Identical, therefore, substantially equivalent |
| mA Range | 10-1000 | 10-1000 | Identical, therefore, substantially equivalent |
| Focal spot - Smart Focal<br>Spot | | | Identical, therefore, substantially |
| | x- and z-deflection | x- and z-deflection | equivalent |
| Couch | | | |
| Couch | Noah Couch | Noah Couch | Identical, therefore, substantially<br>equivalent |
| Couch Vertical Range | Minimum Height - 430 mm | Minimum Height - 430 mm | Identical, therefore, substantially<br>equivalent |
| Couch Horizontal Range | -2143 mm | -2143 mm | Identical, therefore, substantially<br>equivalent |
| Scannable Surview<br>Range | 1940mm | 1940mm | Identical, therefore, substantially<br>equivalent |
| Scannable axial Range | 2000mm | 2000mm | Identical, therefore, substantially<br>equivalent |
| Scannable helical Range | 1900mm | 1900mm | Identical, therefore, substantially<br>equivalent |
| Couch Speed Range | 1 mm/sec – 600 mm/sec | 1 mm/sec – 600 mm/sec | Identical, therefore, substantially<br>equivalent |
| Acceleration | 800 mm/Sec^2 | 800 mm/Sec^2 | Identical, therefore, substantially<br>equivalent |
| Couch Max Load<br>Capacity | High Performance: 675 lbs. (307 kg)<br>Utilizing RTP flat tabletop optional<br>accessory: 628 lbs. (285 kg) | High Performance: 675 lbs. (307<br>kg)<br>Utilizing RTP flat tabletop<br>optional accessory: 628 lbs. (285<br>kg) | Identical, therefore, substantially<br>equivalent |
| Couch accessories | Infant Cradle, Paper roller, Varian Camera<br>Adaptor, Oncology flat tabletop | Infant Cradle, Paper roller, Varian<br>Camera Adaptor, Oncology flat<br>tabletop | Identical, therefore, substantially<br>equivalent |
| Clinical Applications: Dose Tools | |…